Warnings
For external use only. Avoid contact with eyes and mucous membranes. May cause irritation, redness, dryness, or peeling. Stop use and ask a doctor if irritation becomes severe. Do not use on broken or irritated skin.
15% Azelaic Acid Cream
FDA Label NDC 88114-001
7 label sections · Submitted to the FDA by Hongkong King Shiu Technology Limited · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hongkong King Shiu Technology Limited for the product 15% Azelaic Acid Cream (NDC 88114-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
WATER
GLYCERIN
PROPYLENE GLYCOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
DIMETHICONE
HYDROGENATED POLYDECENE
POTASSIUM CETYL PHOSPHATE
POLYACRYLATE CROSSPOLYMER-6
METHYLPROPANEDIOL
HYDROXYACETOPHENONE
POLYACRYLAMIDE
ALLANTOIN
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
C13-14 ISOPARAFFIN
ISOHEXADECANE
XANTHAN GUM
DISODIUM EDTA
SODIUM HYALURONATE
CAPRYLHYDROXAMIC ACID
POLYSORBATE 80
LAURETH-7
DIPOTASSIUM PHOSPHATE
SORBITAN OLEATE
GLYCERYL CAPRYLATE
Indications & Usage
For the management of acne
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Purpose
Acne treatment
Dosage & Administration
Cleanse the skin thoroughly before applying. Apply a thin layer to the affected area and rub in gently until absorbed. Use once or twice daily, or as directed by a healthcare professional.
Package Label.Principal Display Panel
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